Does Dual Therapy Hasten Antidepressant Response?

Completed · Phase 4

Conditions studied: Major Depressive Disorder

In brief

This study will utilize a randomized double-blind design to evaluate whether initial treatment with two anti-depressant medications (escitalopram and bupropion) results in more rapid remission and greater over-all remission rates than either monotherapy in 240 depressed subjects.

Key facts

Study ID

NCT00519428

Run by

New York State Psychiatric Institute

People needed

245

Starts

2007-08-01

Expected to finish

2012-03-01

Last updated by the study team

2017-10-04

Who can join

Age: 18 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Men and women ages 18-65
• Major Depressive Disorder as primary diagnosis
• Physically healthy
• Signs informed consent
• Montgomery Asberg Depression Rating Scale (MADRS) >= 22

You may not qualify if…

• Bipolar Disorder (ie, Bipolar I, Bipolar II, Bipolar NOS)
• Life-time history of psychosis
• Current (ie, last 6 months) drug or alcohol abuse or dependence (except nicotine)
• Currently taking effective antidepressant medication
• Prior adequate treatment in current depressive episode with a selective serotonin re-uptake inhibitor (SSRI), bupropion (BUP) or bupropion (BUP) + a selective serotonin re-uptake inhibitor (SSRI) ("adequate" is defined as >= 4 weeks taking >= 2/3 Physician's Desk Reference (PDR) maximal dose
• Most recent antidepressant was within 5 weeks for fluoxetine and 1 week for all others
• Currently taking a medication contraindicated with either study medication
• Life time history of anorexia or bulimia
• Life time history of seizure or known increased seizure risk (e.g., history of significant brain trauma, taking pro-convulsant medication, known anatomical brain lesion)
• Currently taking psychoactive medication deemed to be necessary (including but not limited anticonvulsants, antidepressants, antipsychotics, steroids, and B-blockers); occasional use of hypnotics (ie, less than three times per week) will be allowed
• Unstable medical condition (ie, condition not adequately stabilized for >= 3 months)
• Prior intolerance to escitalopram (ESC) or bupropion (BUP)
• Inadequate understanding of English (for US site; Canadian site permits French fluency)
• Currently pregnant or breast-feeding; fecund women not using adequate contraceptive methods

Where it is running

• New York State Psychiatric Institute — New York, New York, United States
• University of Ottawa, Institute of Mental Health Research — Ottawa, Ontario, Canada

Full record on ClinicalTrials.gov

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